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Nutritional and Metabolic DiseasesMOMSNCT07194577

Effect of Moringa Oleifera Dehydrated Leaf Powder on the Components of Metabolic Syndrome in Mexican Adults.

A study testing Moringa oleifera in people with Nutritional and Metabolic Diseases and Metabolic Syndrome, run by Universidad de Colima at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: The increase in chronic degenerative diseases caused by Metabolic Syndrome (MS) has prompted the search for natural alternatives to develop new medications and to know the mechanism and dosages for their proper use. Read more about this study

Who is it for?
Ages 25 to 59 years
What is being tested?
Moringa oleifera
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteMexico
Study dates
5 Jan 2023to 30 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Beneficiaries of the medical consultation of the Instituto Mexicano del Seguro Social (IMSS), Colima
  • - Female and male gender
  • People with 3 diagnostic variables of metabolic syndrome according to the standardization of criteria established for the diagnosis of Metabolic Syndrome (2009).
  • Patients under treatment for components of metabolic syndrome (dyslipidemia, diabetes, arterial hypertension)
  • Signed informed consent

Who cannot join

  • Conditions that do not allow blood collection
  • Patients with metabolic syndrome who currently follow a nutritional plan and/or do exercise
  • Pregnant women
  • Smokers
  • Patients with hypothyroidism and hyperthyroidism, cancer, renal failure and/or liver cirrhosis
  • Patients with any complication of diabetes mellitus
Show all 15Show fewer
  • Patients on insulin therapy
  • People who take botanical extracts or a multivitamin
  • People with food allergies
  • Acute infection in progress at the time of blood sample collection
  • Patients must not be participating in another study alternately
  • Elimination Criteria
  • Insufficient, coagulated or hemolyzed serum sample.
  • Patients who interrupt treatment or who do not wish to continue.
  • Patients who present side effects (nausea, vomiting, diarrhea, stomach pain) or any symptom related to discomfort, allergy or intolerance with the consumption of Moringa oleifera leaf powder that does not disappear in a period of 3 days.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Unidad de Medicina Familiar No.19, Instituto Mexicano del Seguro Social

    Colima, Centro, 28000

Other trials in Mexico

About this study

Official title: "Effect of Moringa Oleifera Dehydrated Leaf Powder on the Components of Metabolic Syndrome in Mexican Adults. Double-blind Randomized Clinical Trial. Phase II"

Background: The increase in chronic degenerative diseases caused by Metabolic Syndrome (MS) has prompted the search for natural alternatives to develop new medications and to know the mechanism and dosages for their proper use. To date, evidence of the potential use of moringa in the context of metabolic diseases such as diabetes mellitus 2, obesity, and dyslipidemia is available. However, before they can be used as a treatment for metabolic diseases in humans, clinical studies must be carried out to establish the consistency of its medicinal efficacy and the safest modalities of its administration. Objective: To compare the effect of Moringa oleifera dehydrated leaf powder vs a placebo on the components of metabolic syndrome in mexican adults. Material and methods: Double blind randomized clinical trial, phase II. 42 adults diagnosed with MS treated at the family medical consultation of Clinic 19 of the IMSS Colima will be randomly assigned to 2 groups: intervention group (MO powdered leaf capsules, 5.5 grams per day) and placebo group (starch capsules, 5.5 grams per day). The data collected will be weight, height, blood pressure, and waist circumference, and blood tests include glucose, lipid profile [triglycerides, total cholesterol, HDL cholesterol], glycosylated hemoglobin. Both groups will be evaluated before starting treatment and 8 weeks later, after completing the treatment. Resources and infrastructure: The laboratory exams will are carried out in HGZ1 no.1 of the IMSS.

Read the detailed description
  1. . Data collection. The patients are being recruited from the medical consultation of the UMF 19 of the IMSS Colima. Participants must have a previous Metabolic Syndrome diagnosis in their medical record (3 or more diagnostic variables according to the 2009 standarization by the International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity).
  2. . Study groups. 1) Intervention group [moringa oleifera leaf powder capsules of 0.6 g each]. 5.5 grams a day divided into 3 doses: 3 capsules of 0.6 g each in the morning, 3 capsules of 0.6 g each in the afternoon, 3 capsules of 0.6 g each at night]. 2) Placebo group [5.5 grams of placebo (corn starch) per day divided into 3 doses: 3 capsules of 0.6 g each in the morning, 3 capsules of 0.6 g each in the afternoon, 3 capsules of 0.6 g each at night].
  3. . Randomization and blinding. Computer-generated random numbers were used for simple randomization of subjects to the intervention group (Group A) and placebo group (Group B). Neither the patients nor the principal investigator know to which group subjects belong to (experimental or placebo) until the final results of the study are available.
  4. . Preparation of treatment and placebo. For the present study, a sample size of 42 patients was calculated. Each person will consume nine capsules #00 per day (0.63 g each) for a period of 8 weeks. 504 capsules per person will be needed, which is equivalent to a total of 21,168 capsules , of which 10,584 will be Moringa oleifera leaf powder and 10,584 corn starch as an excipient. Due to the nature of the study (double blind), all capsules are black so there is no way to see the contents inside the capsules. Both the raw material (#00 capsules, Moringa oleifera leaf powder (10 kg), starch (10 kg)) and the encapsulation service were provided by the company Encapsuladoras México, based in Chihuahua, Chihuahua. This guarantees a quality product with excellent hygiene standards and precision in the content of the capsules.
  5. . Follow-up and adherence to treatment. Both groups (A and B) undergo baseline analyzes before receiving any treatment to ensure that they meet the inclusion criteria and have no metabolic or organ risk. In case of corroborating any lack of control in a patient (monitored with the baseline analysis), the treating physician will make the pertinent adjustment with the medications according to the guidelines and procedures of the HGZ No. 1 of the IMSS Colima. Both groups receive their total capsule doses (504 capsules) divided into two doses with 252 capsules each (one dose for each month). The daily dose contain 5.5 g of Moringa oleifera or placebo (corn starch). Participants are instructed to consume 9 capsules per day divided into 3 doses: 3 capsules in the morning, 3 capsules in the afternoon, 3 capsules in the evening; capsules should be taken before each corresponding meal time (breakfast, lunch, dinner). This goes on for a period of 8 weeks. The delivery of the capsules takes place outside the medical consultation of the Family Medical Unit #19 of the IMSS Colima once the results of the baseline laboratory analyzes are obtained. First month of treatment is given, the patients are summoned again and the following month of treatment is given. To ensure a minimum adherence of 80%, a weekly format is given to the participants together with the capsules. Fort he follow-up, a Whatsapp group was created for motivation and weekly reminders, and phone calls are made once a week to answer questions and find out about follow-up. At the end of their treatment, the participants are summoned again to take final measurements and laboratory analysis.
Being tested
Moringa oleifera, Placebo
Keywords
Metabolic syndrome, Moringa oleifera, Diabetes Mellitus type 2, Dyslipidemia
Medical subject headings
Nutritional and Metabolic Diseases, Metabolic Syndrome, Diabetes Mellitus, Type 2, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moringa oleiferaDietary supplement

    5.6 grams of Moringa oleifera Lam dried leaf powder administered orally per day (as nine 0.5 g capsules), divided into three doses (three capsules with breakfast, three with lunch, and three with dinner) for 8 weeks.

  • PlaceboDietary supplement

    Starch placebo administered orally per day (as nine 0.5 g capsules), divided into three doses (three capsules with breakfast, three with lunch, and three with dinner) for 8 weeks.

Study groups in NCT07194577
Study groupRoleWhat they receive
Moringa oleiferaExperimentalTo determine if Moringa oleifera dried leaf powder has an effect * in the components of metabolic syndrome in adults compared to placebo. 5.5 grams of Moringa oleifera Lam leaf powder per day (9 capsules with 0.6 g each) divided into 3 doses - 3 with breakfast, 3 with lunch, 3 with dinner - daily for 8 weeks.
Receives: Dietary Supplement: Moringa oleifera
PlaceboPlacebo comparatorTo determine if Moringa oleifera dried leaf powder has an effect * in the components of metabolic syndrome in adults compared to placebo. Starch capsules, (9 capsules with 0.6 g each) divided into 3 doses - 3 with breakfast, 3 with lunch, 3 with dinner - daily for 8 weeks.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the prevalence of Metabolic Syndrome

    The change in the proportion of participants meeting the diagnostic criteria for Metabolic Syndrome (according to the NCEP ATP III citeria) from baseline to 8 weeks. The outcome is reported as the difference in prevalence rates between the intervention and placebo groups.

    Measured: 8 weeks

Secondary outcomes (10)

  1. Compare the effect of body mass index (BMI) in the experimental group vs. placebo group

    Weight (kg) and height (m) will be combined to report BMI in kg/m^2.

    BMI classification kg/m2:

    Normal range 18.5-24.9 Overweight > 25 Obesity > 30 (82). According to the WHO (2023) and the NIH (2022), an absolute reduction of ≥5% from the initial BMI is considered clinically relevant in the general population, ≥10% in people with obesity (BMI ≥30) or comorbidities (diabetes, hypertension) A reduction of ≥5% between the baseline and final measurements will be considered an improvement.

    Measured: This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention endsThis measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

  2. Compare the effect of waist circumference in the experimental group vs. placebo group

    Waist circumference for Hispanics >94 cm in men and >88 cm in women. A 5-10% reduction from baseline WC improves insulin sensitivity and lipid profile. The formula is calculated as follows:

    Percentage reduction = [(baseline value - final value)/ baseline value] x 100

    Measured: This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

  3. Compare the effect of blood pressure in the experimental group vs. placebo group

    Elevated systolic blood pressure values is >130 mmHg, and is associated with an increased risk of organ damage and cardiovascular events. A reduction in SBP >5 mmHg between baseline and final measurement will be considered an improvement.

    Elevated diastolic blood pressure is >85 mm/Hg (Antihypertensive drug treatment in a patient with a history of hypertension is an alternative indicator). A reduction in DAS >3 mm/Hg between baseline and final measurement will be considered improvement.

    Measured: This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

  4. Compare the effect of fasting glucose in the experimental group vs. placebo group

    Elevated fasting glucose >100 mg/dL (Pharmacological treatment for elevated glucose is an alternative indicator). The American Diabetes Association (ADA) and the World Health Organization (WHO) consider a clinically significant improvement in studies with natural interventions (such as Moringa oleifera) when there is a reduction in fasting glucose of ≥20 mg/dL (1.1 mmol/L) in the diabetic population, or ≥10 mg/dL (0.55 mmol/L) in prediabetes.

    A reduction of ≥10 mg/dL between the baseline and final measurement will be considered an improvement.

    Measured: This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

  5. Compare the effect of HDL-Cholesterol in the experimental group vs. placebo group

    Adequate values for men: <40 mg/dL (1.0 mmol/L); for women: <50 mg/dL (1.3 mmol/L) (Pharmacological treatment for reduced HDL-C is an alternative indicator). According to the AHA/ACC and NLA guidelines (2023), a clinically relevant improvement is considered to be an absolute increase in HDL of ≥5 mg/dL (0.13 mmol/L) in the general population, and ≥10 mg/dL (0.26 mmol/L) in patients with diabetes or metabolic syndrome.

    An increase of ≥5 mg/dL between the baseline and final measurements will be considered an improvement.

    Measured: This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

  6. Compare the effect of triglycerides in the experimental group vs. placebo group

    Normal values >150 mg/dL (1.7 mmol/L) (Pharmacological treatment for elevated triglycerides is an alternative indicator). According to the AHA/ACC (2023) and the National Lipid Association (2023), a 20-30% percentage reduction is considered clinically relevant. The formula is calculated as follows:

    Percent reduction = [(baseline value - final value)/ baseline value] x 100

    Measured: This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

  7. Compare the effect of total cholesterol in the experimental group vs. placebo group

    Normal values <200 mg/dL Reduction will be considered of 5-10% from baseline. The formula used is Percent reduction = [(baseline value - final value)/ baseline value] x 100

    baseline value

    Measured: This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

  8. Compare the effect of LDL-Cholesterol in the experimental group vs. placebo group

    Normal values <100 mg/dL.

    Change is 30-50% reduction from baseline (for statins or combination therapies) . The formula is calculated as follows:

    Percent reduction = [(baseline value - final value) / baseline values] x 100

    Measured: This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

  9. Compare the effect of non- HDL-Cholesterol in the experimental group vs. placebo group

    Normal values <130 mg/dL .

    Change is 20-30% reduction from baseline. The formula is calculated as follows:

    Percent reduction = [(baseline value - final value)/ baseline value] x 100

    Measured: This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

  10. Compare the effect of glycated hemoglobin in the experimental group vs. placebo group

    According to the American Diabetes Association, a diagnosis of type 2 diabetes based on glycated hemoglobin is made when HbA1c is 6.5% or higher, and high risk of this condition is present with an HbA1c of 5.7-6.4%. A reduction in HbA1c of >0.5% between baseline and final measurement is considered an improvement in diabetic patients.

    A reduction of ≥0.5% between baseline and final measurement will be considered an improvement.

    Measured: This measurement will be taken at the beginning of the protocol, and then 8 weeks later, when the intervention ends

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2025
  2. Study start5 Jan 2023
  3. Primary completion30 Jul 2024
  4. Study completion30 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
42 adults diagnosed with metabolic syndrome will be randomly assigned to either the intervention group or the placebo group. The data collected will be weight, height, blood pressure, and waist circumference, and blood tests include glucose, lipid profile \[triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol\], and glycosylated hemoglobin. Both groups will be evaluated before starting treatment and 8 weeks later, after completing the treatment.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07194577
Sponsor's protocol ID
MOD
Acronym
MOMS
Status last verified
Sep 2025
First submitted
12 May 2025
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: At the moment we will not share the information until having preliminary results.

Publications

  • Writing Committee Members; Virani SS, Newby LK, Arnold SV, Bittner V, Brewer LC, Demeter SH, Dixon DL, Fearon WF, Hess B, Johnson HM, Kazi DS, Kolte D, Kumbhani DJ, LoFaso J, Mahtta D, Mark DB, Minissian M, Navar AM, Patel AR, Piano MR, Rodriguez F, Talbot AW, Taqueti VR, Thomas RJ, van Diepen S, Wiggins B, Williams MS. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2023 Aug 29;82(9):833-955. doi: 10.1016/j.jacc.2023.04.003. Epub 2023 Jul 20.

    PubMed 37480922

  • Taweerutchana R, Lumlerdkij N, Vannasaeng S, Akarasereenont P, Sriwijitkamol A. Effect of Moringa oleifera Leaf Capsules on Glycemic Control in Therapy-Naive Type 2 Diabetes Patients: A Randomized Placebo Controlled Study. Evid Based Complement Alternat Med. 2017;2017:6581390. doi: 10.1155/2017/6581390. Epub 2017 Nov 28.

    PubMed 29317895

  • Haber SL, McMahon RP, Barajas J, Hayes AR, Hussein H. Effects of Moringa oleifera in patients with type 2 diabetes. Am J Health Syst Pharm. 2020 Oct 30;77(22):1834-1837. doi: 10.1093/ajhp/zxaa255. No abstract available.

    PubMed 32960218

  • Chan Sun M, Ruhomally ZB, Boojhawon R, Neergheen-Bhujun VS. Consumption of Moringa oleifera Lam Leaves Lowers Postprandial Blood Pressure. J Am Coll Nutr. 2020 Jan;39(1):54-62. doi: 10.1080/07315724.2019.1608602. Epub 2019 May 7.

    PubMed 31063434

  • Wang F, Bao Y, Zhang C, Zhan L, Khan W, Siddiqua S, Ahmad S, Capanoglu E, Skalicka-Wozniak K, Zou L, Simal-Gandara J, Cao H, Weng Z, Shen X, Xiao J. Bioactive components and anti-diabetic properties of Moringa oleifera Lam. Crit Rev Food Sci Nutr. 2022;62(14):3873-3897. doi: 10.1080/10408398.2020.1870099. Epub 2021 Jan 6.

    PubMed 33401950

  • Gomez-Martinez S, Diaz-Prieto LE, Vicente Castro I, Jurado C, Iturmendi N, Martin-Ridaura MC, Calle N, Duenas M, Picon MJ, Marcos A, Nova E. Moringa oleifera Leaf Supplementation as a Glycemic Control Strategy in Subjects with Prediabetes. Nutrients. 2021 Dec 24;14(1):57. doi: 10.3390/nu14010057.

    PubMed 35010932

  • Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.

    PubMed 19805654

  • Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.

    PubMed 9686693

  • Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.

    PubMed 30586774

Questions about this trial

What is this clinical trial studying?

A study testing Moringa oleifera in people with Nutritional and Metabolic Diseases and Metabolic Syndrome, run by Universidad de Colima at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the prevalence of Metabolic Syndrome (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07194577, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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